Quality Engineer

Job Title

Roles and Responsibilities:

- Work with product engineering to develop reliability requirements, establish a reliability plan and perform appropriate analyses to ensure that new products meet all of the requirements.

- Work with the project teams to develop a reliability plan to document tasks, methods, tools, tests and analyses that are required for the success of new products.

- Assist engineering teams to achieve warranty reduction and improve customer satisfaction by leading quality efforts on problem identification, failure root cause analysis, corrective action development and resolution verification.

- May participate and/or conduct training and workshops on quality and reliability engineering, robustness, and statistics as necessary within product engineering.

- Participate in product design and reliability reviews during new product development to ensure robustness of product design and manufacturing processes.

- Perform statistical data analysis, regression modeling, Weibull Analysis, hazard analysis, reliability growth assessment and prediction, target setting, warranty trend analysis and spending forecast for new products.

- Perform Design FMEAs on all new products and recommend design changes to improve product reliability.

- Work with Manufacturing to evaluate and qualify new technology and new processes implemented in manufacturing.

- Conduct reliability testing on new and existing products. Highly Accelerated Life Testing and Highly Accelerated Stress Testing to identify product failure modes. Validate and track product requirements through development.

- Conduct accelerated life testing on both the component and system level to provide feedback on design life which can be used to evaluate failure and safety risks within the project.

- Certified Reliability Engineer - Preferred

- Six Sigma GB/BB - Preferred

Requirements:

- B.S. in a technical field, Electrical, Mechanical, Bioengineering, Software Engineering etc. Masters degree preferred.

- Electrical and software development experience is preferred

- Material science or plastics engineering experience is preferred

- Expertise with Design Quality, Reliability and Safety/Compliance is a must.

- ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred.

- Strong understanding of medical device industry regulatory requirements including but not limited to MDSAP participating countries, ISO Standards (ISO 13485 and ISO 14971), EUMDR, IEC 62304, IEC 60601, IEC 62366.

- Certified Reliability Engineer - Preferred

- Six Sigma GB/BB - Preferred

- 6+ years of experience in design quality, quality engineering, or reliability